Amiodarone Hydrochloride
- Product NDC
- 84549-153
- 11-digit product format
- 845490153
- Labeler code
- 84549
- Product ID
- 84549-153_462a9d14-baa5-8d4b-e063-6394a90a0d58
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amiodarone hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- ProPharma Distribution
- Application
- ANDA076217
- Marketing category
- ANDA
- Marketing start
- 2002-10-14
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amiodarone Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMIODARONE HYDROCHLORIDE | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 976728SY6Z |
| Rxcui | 1663224 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84549-153-03 | Amiodarone Hydrochloride | 3 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 3 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84549-153-03 | 84549015303 | 3 mL in 1 VIAL, GLASS (84549-153-03) | 3 ml | 2025-08-27 | No | No | Historical |